) recently received a major boost with the US Food and Drug
Administration (FDA) approving Botox (onabotulinumtoxinA) for the
treatment of patients suffering from overactive bladder (OAB)
with symptoms of urge urinary incontinence, urgency and
frequency. The drug can be used in adults with OAB, who have not
responded adequately to, or, are intolerant to anticholinergic
medication (current standard of care).
Allergan's supplemental Biologics License Application (sBLA)
for Botox for the said indication was supported by data from two
phase III trials. The trials demonstrated that patients who were
treated with 100 units of Botox experienced significant
reductions in the frequency of urinary incontinence episodes,
compared to placebo.
We note that OAB is the eighth indication for which Botox has
received approval in the US. The last was in August 2011, when
the regulatory body approved Botox for the treatment of
neurogenic OAB in adults. The other uses of the drug comprise
treatment of chronic migraine headache, treatment of increased
muscle stiffness in elbow, wrist, and fingers in adults with
upper limb spasticity; treatment of abnormal head position and
neck pain that happens with cervical dystonia in patients aged 16
years and above; and treatment of certain types of eye muscle
problems (strabismus) or abnormal spasm of the eyelids
(blepharospasm) in patients aged 12 years and above.
Botox is also used to treat the symptoms of severe underarm
sweating in adults. Additionally, Botox Cosmetic is used to
temporarily improve the look of moderate to severe frown lines
between the eyebrows (glabellar lines) in adults.
We view the approval of Botox for the treatment for OAB as a
major positive for Allergan. However, we remain concerned about
Botox's sales post the re-entry of Merz Pharmaceuticals Xeomin in
the market. In Mar 2012, an injunction against Xeomin was issued,
which was valid till Jan 9, 2013.
Allergan carries a Zacks Rank #3 (Hold) in the short run.
Pharma companies that currently look better-positioned include
Johnson & Johnson
). All three are Zacks Rank #2 (Buy) stocks.
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